Trial intelligence / Profile preview

hOKT3γ1 (Ala-Ala) in Type 1 Diabetic Islet Allograft Recipients

NCT00285194Phase 2

Key facts

Status: Completed
Start: Apr 2000
Primary completion: Jan 2004
Countries: 1
Sponsor: University of Minnesota
Modality: Monoclonal Antibodies

Drugs: teplizumab
Conditions: type 1 diabetes mellitus (T1D)

Overview

Phase 2, open-label, single-arm trial of teplizumab in type 1 diabetes mellitus (T1D), sponsored by University of Minnesota. Primary endpoint: Safety, tolerability, immune activity, and pharmacokinetics of hOKT3γ1 (Ala-Ala) antibody induction therapy up to 1 year. Started Apr 2000; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

hOKT3γ1 (Ala-Ala) + Sirolimus + Tacrolimus + Islet Allograft
Subjects receive hOKT3γ1 (Ala-Ala) and sirolimus induction immunotherapy combined with sirolimus and delayed tacrolimus maintenance immunosuppression alongside Allogeneic Islets of Langerhans.

Who it enrols

Adults with Type 1 diabetes undergoing primary islet allotransplant, with poor glucose control (HbA1c 10-12%) despite intensive management, negative C-peptide, and no history of malignancy, active infection, or previous islet/pancreas transplant.

Endpoints

Primary

Safety, tolerability, immune activity, and pharmacokinetics of hOKT3γ1 (Ala-Ala) antibody induction therapyUp to 1 year

Secondary

Proportion of subjects with full islet graft functionUp to 1 year
Proportion of subjects with partial islet graft functionUp to 1 year
Proportion of subjects with islet graft lossUp to 1 year

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